# Long-Term Safety of Anti-COVID-19 mRNA Vaccines in Patients with Systemic Lupus Erythematosus and Lupus-like Diseases with a Previous History of Myocarditis

## TL;DR

This study shows that mRNA-based anti-COVID-19 vaccines are safe in the long-term for patients with lupus and a history of myocarditis.

## Contribution

The paper provides long-term safety data for mRNA vaccines in patients with autoimmune diseases and prior myocarditis.

## Key findings

- No myocarditis recurrence or disease flare was observed in patients after vaccination.
- All patients were in low disease activity or remission at the last follow-up.
- No significant changes in inflammation or myocardial injury markers were noted.

## Abstract

Non-viral myocarditis is rare but relatively more frequent in patients with systemic autoimmune diseases (such as systemic lupus erythematosus, SLE, and allied conditions) than in the general population. In rare cases, mRNA-based vaccines can also trigger non-viral myocarditis. Limited data are available about the cardiac safety of mRNA vaccines in this subset of patients. Here, we report data from a third-level hospital on long-term safety, leveraging on a previously described cohort of 13 consecutive patients with SLE, Undifferentiated (UCTD) and Mixed Connective Tissue disease (MCTD), and a history of myocarditis, who had received anti-COVID-19 vaccination between April 2021 and January 2022. Demographics and clinical data (including validated clinometric for SLE) were collected at baseline, at the first available visit following the primary vaccination cycle, after an additional 12 months, and at the last available follow-up after at least 36 months. Twelve patients, seven females, ten with SLE, one MCTD, and one UCTD, had a median follow-up of 41 (35–45) months. One patient was lost at follow-up. No disease flare or sign of myocarditis recurrence were observed. At last visit, all patients were in a low disease activity state (LLDAS), and all but one were in remission, according to the Definition of Remission in SLE (DORIS) criteria. No significant variations in disease activity or damage accrual nor in markers of inflammation and myocardial injury were observed. Our data suggest that mRNA-based anti-COVID-19 vaccines in patients with previous autoimmune myocarditis in the context of SLE and allied conditions have a good long-term safety profile.